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细分后获得的片剂各部分的均匀性是否存在差异?——使用X射线显微断层扫描的初步评估

Are There Differences in the Homogeneity of the Parts of Tablets Obtained after Subdivision?-A Preliminary Assessment Using an X-ray Microtomography.

作者信息

Meisner Michał, Kuśnierz Piotr, Duda Piotr, Wilczyński Sławomir, Sarecka-Hujar Beata

机构信息

Department of Basic Biomedical Science, Faculty of Pharmaceutical Sciences in Sosnowiec, Medical University of Silesia in Katowice, Kasztanowa Str. 3, 41-200 Sosnowiec, Poland.

Institute of Biomedical Engineering, Faculty o Faculty of Science and Technology, University of Silesia, 41-200 Sosnowiec, Poland.

出版信息

Pharmaceutics. 2022 Sep 1;14(9):1850. doi: 10.3390/pharmaceutics14091850.

Abstract

Aim: The study aimed to analyze the weight and homogeneity of the parts of tablets containing carbamazepine and tablets with trazodone hydrochloride, obtained after subdivision with a kitchen knife. X-ray microtomography was used for homogeneity analysis. Methods: 30 tablets with carbamazepine and 30 tablets with trazodone hydrochloride were analyzed in terms of weight uniformity after subdivision. Then, seven tablets of each type were analyzed using an X-ray microtomography (Phoenix vǀtomeǀx, General Electric). The absorption of X-rays by an object is proportional to its density. In turn, measurement of the density of the analyzed object in a microtomographic image is the grayscale level. Based on the correlation between the grayscale value and the reference density, from the calibration phantom, we were able to determine the density of any area of the tablet’s scan. Results: During the subdivision, the weight loss exceeded 3% for two carbamazepine tablets, while for trazodone tablets, none lost more than 3%, which is the limit recommended by Food and Drug Administration (FDA). As to the density of the tablets resulting from the microtomographic analysis, two of the whole tablets containing trazodone hydrochloride had a significantly higher density than the remainder (p < 0.001). Similarly, some differences in density were observed in the analysis of the density of tablets of carbamazepine (p = 0.008). Parts of one of the analyzed tablets with trazodone obtained after subdivision differed in terms of pixel brightness, thus density. On the other hand, the uniform density was observed for parts of the split tablets containing carbamazepine. Conclusions: Parts of the trazodone hydrochloride tablets obtained after subdivision differed in terms of homogeneity and weight. Microtomographic methods may be an interesting and useful method for evaluating the uniformity of compounds in solid dosage forms.

摘要

目的

本研究旨在分析用菜刀分割后含卡马西平的片剂以及含盐酸曲唑酮的片剂各部分的重量和均匀性。采用X射线显微断层扫描技术进行均匀性分析。方法:对30片卡马西平片和30片盐酸曲唑酮片进行分割后的重量均匀度分析。然后,使用X射线显微断层扫描仪(通用电气公司的Phoenix vǀtomeǀx)对每种类型的7片片剂进行分析。物体对X射线的吸收与其密度成正比。反过来,在显微断层图像中测量被分析物体的密度就是灰度级。根据校准体模中灰度值与参考密度之间的相关性,我们能够确定片剂扫描任何区域的密度。结果:在分割过程中,两片卡马西平片的重量损失超过了3%,而盐酸曲唑酮片没有一片损失超过3%,这是美国食品药品监督管理局(FDA)推荐的限度。至于显微断层分析得出的片剂密度,两片完整的含盐酸曲唑酮片剂的密度明显高于其余片剂(p < 0.001)。同样,在卡马西平片剂密度分析中也观察到了一些密度差异(p = 0.008)。分割后得到的一片含盐酸曲唑酮的被分析片剂的各部分在像素亮度方面存在差异,因此密度也不同。另一方面,含卡马西平的分割后片剂各部分的密度是均匀的。结论:分割后得到的盐酸曲唑酮片剂各部分在均匀性和重量方面存在差异。显微断层扫描方法可能是评估固体剂型中化合物均匀性的一种有趣且有用的方法。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9b26/9506467/45fdca858e88/pharmaceutics-14-01850-g001.jpg

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